1. ¹Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece
2. ²Division of Public Health, Department of Nursing, University of Athens, Athens, Greece
3. ³First Department of Obstetrics and Gynecology, Alexandra Hospital, University of Athens School of Medicine, Athens, Greece
4. ⁴Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece

Correspondence: Dr C Papadimitriou, Department of Clinical Therapeutics, Alexandra Hospital, University of Athens School of Medicine, Tatoiou 146, Athens, 14671 Nea Erythrea, Greece. E-mail: chr_papadim@yahoo.gr or geothb@yahoo.gr

Received 15 September 2006; Revised 8 October 2007; Accepted 10 October 2007; Published online 19 November 2007.

Abstract

The role of high-dose chemotherapy (HDCT) in epithelial ovarian cancer (EOC) remains controversial. This study was initiated to compare the efficacy and tolerability of HDCT as a consolidation approach in women with chemosensitive advanced EOC (FIGO stages IIC–IV). Patients who had achieved their first clinical complete remission after six cycles of conventional paclitaxel and carboplatin combination chemotherapy were randomly assigned to receive or not high-dose melphalan. The primary objective was to compare time to disease progression (TTP). A total of 80 patients were enrolled onto the trial. Patients who were randomized to receive HDCT were initially treated with cyclophosphamide 4 g/m² for PBPC mobilization. HDCT consisted of melphalan 200 mg/m². Of the 37 patients who were allocated to HDCT, 11 (29.7%) did not receive melphalan either due to patient refusal (n=5) or due to failure of PBPC mobilization (n=6). In an intent-to-treat analysis, there were no significant differences between the two arms in TTP (P=0.059) as well as in overall survival (OS) (P=0.38).